WARNING
FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED DURING THERAPY WITH VIDEX USED ALONE OR IN COMBINATION REGIMENS IN BOTH TREATMENT-NAIVE AND TREATMENT-EXPERIENCED PATIENTS, REGARDLESS OF DEGREE OF IMMUNOSUPPRESSION. VIDEX SHOULD BE SUSPENDED IN PATIENTS WITH SUSPECTED PANCREATITIS AND DISCONTINUED IN PATIENTS WITH CONFIRMED PANCREATITIS (SEE WARNINGS).
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION, INCLUDING DIDANOSINE AND OTHER ANTIRETROVIRALS. FATAL LACTIC ACIDOSIS HAS BEEN REPORTED IN PREGNANT WOMEN WHO RECEIVED THE COMBINATION OF DIDANOSINE AND STAVUDINE WITH OTHER ANTIRETROVIRAL AGENTS. THE COMBINATION OF DIDANOSINE AND STAVUDINE SHOULD BE USED WITH CAUTION DURING PREGNANCY AND IS RECOMMENDED ONLY IF THE POTENTIAL BENEFIT CLEARLY OUTWEIGHS THE POTENTIAL RISK (SEE WARNINGS AND PRECAUTIONS: PREGNANCY, REPRODUCTION, AND FERTILITY).
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VIDEX SUMMARY
VIDEX® (didanosine) is a brand name for didanosine (ddI), a synthetic purine nucleoside analogue active against the Human Immunodeficiency Virus (HIV). VIDEX Pediatric Powder for Oral Solution is supplied for oral administration in 4- or 8-ounce glass bottles containing 2 or 4 grams of didanosine, respectively. Didanosine is also available as an enteric-coated formulation (VIDEX® EC Delayed-Release Capsules). Please consult the prescribing information for VIDEX EC (didanosine).
VIDEX (didanosine) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection.
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VIDEX NEWS HIGHLIGHTS Media Articles Related to Videx (Didanosine)
New HIV Infections Could End In United States In 30 Years
Source: HIV / AIDS News From Medical News Today [2008.11.20]
STEP Study Shows HIV Vaccine From Merck Does Not Protect Against HIV Infection
Source: Immune System / Vaccines News From Medical News Today [2008.11.17]
Herpes Suppression May Not Prevent HIV Infection
Source: MedicineNet Genital Herpes In Women Specialty [2008.06.20]
Long-Term TITAN Study Evaluates PREZISTA(R)/ritonavir Vs. Lopinavir/ritonavir As Part Of HIV Combination Therapy In Treatment-Experienced Adults
Source: Conferences News From Medical News Today [2008.11.19]
Domestic Strategy For Combating HIV/AIDS In U.S. Should Mirror PEPFAR, Opinion Piece Says
Source: HIV / AIDS News From Medical News Today [2008.11.18]
Published Studies Related to Videx (Didanosine)
Didanosine, lamivudine, and efavirenz versus zidovudine, lamivudine, and efavirenz for the initial treatment of HIV type 1 infection: final analysis (48 weeks) of a prospective, randomized, noninferiority clinical trial, GESIDA 3903. [2008.10.15]
Low-level K65R mutation in HIV-1 reverse transcriptase of treatment-experienced patients exposed to abacavir or didanosine. [2007.10.01]
Stavudine but not didanosine as part of HAART contributes to peripheral lipoatrophy: a substudy from the Antiretroviral Regimen Evaluation Study (ARES). [2007.09]
Baseline genotype as a predictor of virological failure to emtricitabine or stavudine in combination with didanosine and efavirenz. [2007.08]
Phenotypic susceptibility to didanosine is associated with antiviral activity in treatment-experienced patients with HIV-1 infection. [2007.02.01]
Clinical Trials Related to Videx (Didanosine)
Bioequivalence Study of Didanosine in Children Treated for HIV [Not yet recruiting]
Antiretroviral Switch From Didanosine to Tenofovir in HIV/HCV co-Infected Patients [Recruiting]
Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth [Recruiting]
Safety and Efficacy of Two Once Daily Anti Retroviral Treatment Regimens Along With Anti-Tuberculosis Treatment [Recruiting]
Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children [Recruiting]
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